Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial.

INTRODUCTION: Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes. METHODS AND ANALYSIS: A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention. ETHICS AND DISSEMINATION: The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN68786622. PROTOCOL VERSION: 2.0 (16 May 2023).

Improving cardiovascular health in patients with an abdominal aortic aneurysm: development of the cardiovascular risk reduction in patients with aneurysms (CRISP) behaviour change intervention.

BACKGROUND: Abdominal aortic aneurysm (AAA) is an important cardiovascular health problem. Ultrasound screening is proven to reduce AAA mortality and programmes have been implemented in some healthcare systems. Those who are identified as having a small AAA in screening enter into a surveillance programme to monitor AAA size. Individuals in AAA surveillance are at elevated risk of cardiovascular events, which is not currently addressed sufficiently. We aimed to develop a simple intervention to reduce cardiovascular risk, which could be embedded in AAA surveillance pathways. METHODS: Intervention mapping methods were used to co-develop the intervention with individuals with AAA, families/carers, and healthcare staff. We identified "targets for change" by synthesising research evidence and international guidelines and consulting with patients, caregivers and health service providers. We conducted a series of workshops to identify barriers to and facilitators of change and used taxonomies of behaviour change theories and techniques to match intervention strategies to each target. Further stakeholder involvement work helped refine the intervention. RESULTS: The developed intervention focusses on assessment and individually tailored discussion of risk factors, exchanging information, building motivation and action planning, followed by review of progress and problem-solving. Workbooks covering physical activity, diet, stress management, alcohol, smoking, blood pressure and mental health are provided to support behaviour change. The intervention is facilitated by trained healthcare professionals during the patient's AAA screening appointment for the duration that they are in surveillance. DISCUSSION: The developed intervention will now be tested to assess whether it can be integrated with the current AAA screening programme. The developed intervention is a novel approach to reducing cardiovascular disease in the AAA population, it is also the first intervention which tries to do this in this population. TRIAL REGISTRATION: International Clinical Trial Registration: ISRCTN93993995.

Improving balance in community-dwelling elders using trained volunteers within faith-based institutions: a mixed methods feasibility study.

PURPOSE: To investigate the feasibility and acceptability of a volunteer-led balance programme for older adults. METHODS: A feasibility cluster RCT with focus groups were conducted in faith-based institutions. Eligibility criteria were: participants were ≥65 years, able to do five times sit -to-stand, had no falls in the previous six months and had good mental capacity. The intervention included supervised group exercises and exercise booklets for six months, education and a fall poster. Assessments included, TUG, MCTSiB, FTST, FES, mABC, OPQoL and DGLS at baseline, 6 weeks, and 6 months. Feasibility measures included numbers of volunteers, sessions, and volunteers" time commitment, views of participants about sustainability of program using qualitative focus groups and volunteers' ability to deliver programme. RESULTS: Three churches participated with 31 participants in each group. Participants had a mean age of 77.3 years, were 100% British, and 79% female. The sample size estimate for a future trial using TUG, was 79 per group. Focus groups showed perceived social and physical improvements in participants, need to extend the programme to the wider community, and increased confidence, participation and socialisation. CONCLUSION: The community-based balance training in faith-based institutions, was feasible and acceptable in one geographical area and requires evaluation in cohesive diverse communities.Implications for RehabilitationIf an institution or a community is united through faith, culture, national roots, or tradition, then these groups are ideal for such balance rehabilitation programmes, because of the familiarity of the location and people, cohesive culture or their ideology to help their communities.Participants and volunteers perceived improved participation, confidence and socialisation and were keen to continue programme.It is important to develop community-based falls prevention programmes that the National Health Service (NHS) can partially support using volunteers to reduce the burden of falls in the community and for the NHS.

Development of the 'ACT now & check-it-out' intervention to support patient-initiated follow up for Head and Neck cancer patients.

OBJECTIVE: Current Head and Neck cancer (HNC) follow-up models are considered sub-optimal at detecting recurrences. We describe the development of a patient-initiated follow up (PIFU) trial intervention support package, to support HNC patients to engage in PIFU self-care behaviors. METHODS: An intervention mapping approach, informed by evidence synthesis, theory and stakeholder consultation, guided intervention development. Data sources included a patient survey (n = 144), patient interviews (n = 30), 7 workshops with patients (n = 25) and caregivers (n = 3) and 5 workshops with health professionals (n = 21). RESULTS: The intervention ('ACT now & check-it-out') comprises an education and support session with a health professional and an app and/or a booklet for patients. The main targets for change in patient self-care behaviors were: assessing what is normal for them; regularly checking for symptom changes; prompt help-seeking for persistent/new symptoms; self-management of fear of recurrence; engaging with the intervention over time. CONCLUSIONS: We have developed an evidence, person and theory-based intervention to support PIFU self-care behaviors in HNC patients. PRACTICE IMPLICATIONS: A trial is underway to assess the effectiveness and cost-effectiveness of the intervention. If successful, this intervention could be adapted for patients with other cancers or diseases, which is important given the recent shift towards PIFU pathways.

"It helps me to stay on the right path, rather than give in": Mixed-method process evaluation of the ImpulsePal app-based intervention for weight management.

Background: Empirical research indicates that impulsive processes that operate below conscious monitoring can undermine peoples' attempts to change behaviour patterns, especially those that have become habitual. This may, therefore, be a serious challenge for those trying to lose weight. A novel smartphone app-based intervention (ImpulsePal) offers practical strategies to manage impulsive urges to facilitate reductions in the consumption of energy-dense processed food and overeating. Aim: This process evaluation of ImpulsePal aimed to explore what was delivered/received and used, mechanisms of action, and potential contextual factors impacting intervention engagement and outcomes. Methods: A mixed-methods process evaluation, with composite analysis of the quantitative (app usage statistics) and qualitative data (semi-structured interviews), was conducted alongside a feasibility randomised controlled trial with individuals with a body mass index of at least 25 kg/m2 who wanted to lose weight. Results: Of 58 participants receiving ImpulsePal, 56 had successfully shared app usage statistics, and 36 (62%) were interviewed. Although usage statistics indicated reductions in the use of some features, interviews indicated that participants were still using app-recommended strategies without requiring them to open ImpulsPal. Overall, interviews highlighted that participants valued having access to in-the-moment support, felt more aware of their own eating behaviour and influences on it, and felt an increased ability to avoid and reconceptualise, in-the-moment temptations. Conclusion: This process evaluation offers support for a logic model suggesting that impulse management, using ImpulsePal, can promote healthier eating among those motivated to lose weight. It also highlights the necessity of using multimodal methods to explore the delivery and use of digital interventions.

A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial.

BACKGROUND: The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing. METHODS/DESIGN: Community-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4-9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: ACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22.

Promoting participation in physical activity through Snacktivity: A qualitative mixed methods study.

BACKGROUND: Public health guidance acknowledges the benefits of physical activity of any duration. We have proposed a whole-day approach to promoting physical activity called Snacktivity™, which encourages frequent 2-5 minute 'activity snacks' of moderate-to-vigorous intensity. METHODS: Using repeated semi-structured interviews and a think aloud protocol, this study aimed to understand participants' experiences of integrating Snacktivity™ into daily life, to provide insights to refine the delivery of Snacktivity™ interventions. Physically inactive adults recruited via primary care and a community health service engaged with an intervention to encourage Snacktivity™ over three weeks, which included using a Fitbit and linked mobile phone app (SnackApp). Participants took part in semi-structured interviews on two occasions during the intervention, with a sub-group participating in a think aloud study. Three study data sets were generated and independently explored using inductive thematic analysis, with findings combined into a single set of themes. RESULTS: Eleven adults participated in the interview study who were interviewed twice (total interviews completed n = 21, 1 participant declined the second interview), of whom six completed the think aloud study (total voice recordings n = 103). Three main themes emerged from the combined data; lived experience of participating in Snacktivity™, motivation for Snacktivity™ and experiences with the Snacktivity™ technology. Participants undertook a variety of activity snacks, utilising their environment, which they believed improved their psychological wellbeing. Participants were enthusiastic about Snacktivity™, with some stating that activity snacks were more accessible than traditional exercise, but perceived they were often prevented from doing so in the presence of others. Participants were mostly enthusiastic about using the Snacktivity™ technology. CONCLUSION: Participants were able to incorporate Snacktivity™ into their lives, particularly at home, and found this approach acceptable. Participants felt they experienced health benefits from Snacktivity™ although barriers to participation were reported. This study offers insights for translating guidance into practice and supporting people to become more physically active.

The REtirement in ACTion exercise programme and its effects on elements of long term functionality in older adults.

Background: The prevention of mobility-related disability amongst adults is a global healthcare priority. Cost-effective community-based strategies to improve physical function and independence in older adults with mobility limitations are needed. This study investigated the effectiveness of the REtirement in ACTion (REACT) exercise intervention on individual markers of physical function at 6-and 12-months. Methods: The REACT multicentre randomised controlled trial assigned 777 older adults (female, 514; male 263) (mean age 77·6 [SD 6·8] years) with reduced lower limb physical functioning (Short Physical Performance Battery [SPPB] score 4-9) to receive brief healthy ageing advice or a 12-month, group-based, multimodal exercise programme delivered in local communities. Estimated differences in the three individual component scores of the SPPB (strength, balance, gait speed) and physical functional outcomes recorded at 6- and 12-months were assessed. Results: The intervention group demonstrated significant improvements in strength (OR = 1.88, 95% CI = 1.36-2.59, p < 0.001) and balance (OR = 1.96, 95% CI = 1.39-2.67, p < 0.001) at 12-months, but not in gait speed (OR = 1.32, 95% CI = 0.91-1.90, p = 0.139). In comparison to the control group, at six-and 12-months, the intervention group reported statistically significant improvements in Mobility Assessment Tool-Short Form (MAT-SF), physical component score from SF-36 questionnaire, and strength and endurance items of subjectively reported physical activity (PASE 10-item). Greater than 75% adherence (attending ≥48 of the 64 exercise sessions delivered in 12-months) was associated with superior functional outcomes. Conclusion: The REACT exercise programme provides local, regional and national service providers with an effective solution to increase muscle strength and balance in older adults at risk of mobility disability.

Addressing the psychology of weight loss and maintenance: A feasibility study of the Skills for weight loss and Maintenance weight management programme.

OBJECTIVES: Building on prior theory, we aimed to evaluate the feasibility and acceptability of integrating novel, weight loss maintenance strategies into existing weight management programmes. We also piloted recruitment and data collection procedures for future research. DESIGN: Two phases of action research nested within a single-arm feasibility study. The intervention was refined between phases using feedback from intervention fidelity analysis and qualitative exploration of patient and provider experiences. Changes in outcomes were assessed up to 18 months post-baseline. METHODS: One hundred adults with a mean body mass index of 37 kg/m2 were offered the Skills for weight loss and Maintenance (SkiM) intervention. This included existing weight management programme content and additional weight loss maintenance techniques delivered fortnightly for 6 months in local community centres to groups of 11-15 people. RESULTS: Of the 100 participants, 65%, 58% and 56% provided data at 7, 12 and 18 months. Across both phases, the mean initial weight loss was 4.2 kg (95% CI: 2.4-5.9) and 3.1 kg at 18 months (95% CI: .8-5.5). In Phase 2, we observed better weight loss maintenance (.5 kg [13.2%] regain from 7 to 18 months, vs. 1.7 kg [36.2%] in Phase 1). Variation in outcomes, high early dropout rates and qualitative feedback indicated that, although delivery of the intervention and trial procedures was feasible and acceptable, there was scope to refine the intervention to engage a wider range of participants. Intervention fidelity was acceptable, particularly in Phase 2. CONCLUSIONS: The SkiM intervention seems promising, but more research is needed to improve recruitment and retention prior to further evaluation.

Recommendations from Diabetes UK's 2022 diabetes and physical activity workshop.

AIMS: To describe the process and outputs of a workshop convened to identify key priorities for future research in the area of diabetes and physical activity and provide recommendations to researchers and research funders on how best to address them. METHODS: A 1-day research workshop was conducted, bringing together researchers, people living with diabetes, healthcare professionals, and members of staff from Diabetes UK to identify and prioritise recommendations for future research into physical activity and diabetes. RESULTS: Workshop attendees prioritised four key themes for further research: (i) better understanding of the physiology of exercise in all groups of people: in particular, what patient metabolic characteristics influence or predict the physiological response to physical activity, and the potential role of physical activity in beta cell preservation; (ii) designing physical activity interventions for maximum impact; (iii) promoting sustained physical activity across the life course; (iv) designing physical activity studies for groups with multiple long-term conditions. CONCLUSIONS: This paper outlines recommendations to address the current gaps in knowledge related to diabetes and physical activity and calls on the research community to develop applications in these areas and funders to consider how to stimulate research in these areas.

Preventing type 2 diabetes: A research agenda for behavioural science.

AIMS: The aim of this narrative review was to identify important knowledge gaps in behavioural science relating to type 2 diabetes prevention, to inform future research in the field. METHODS: Seven researchers who have published behaviour science research applied to type 2 diabetes prevention independently identified several important gaps in knowledge. They met to discuss these and to generate recommendations to advance research in behavioural science of type 2 diabetes prevention. RESULTS: A total of 21 overlapping recommendations for a research agenda were identified. These covered issues within the following broad categories: (a) evidencing the impact of whole population approaches to type 2 diabetes prevention, (b) understanding the utility of disease-specific approaches to type 2 diabetes prevention such as Diabetes Prevention Programmes (DPPs) compared to generic weight loss programmes, (c) identifying how best to increase reach and engagement of DPPs, whilst avoiding exacerbating inequalities, (d) the need to understand mechanism of DPPs, (e) the need to understand how to increase maintenance of changes as part of or following DPPs, (f) the need to assess the feasibility and effectiveness of alternative approaches to the typical self-regulation approaches that are most commonly used, and (g) the need to address emotional aspects of DPPs, to promote effectiveness and avoid harms. CONCLUSIONS: There is a clear role for behavioural science in informing interventions to prevent people from developing type 2 diabetes, based on strong evidence of reach, effectiveness and cost-effectiveness. This review identifies key priorities for research needed to improve existing interventions.

Development of a Mobile Health Snacktivity App to Promote Physical Activity in Inactive Adults (SnackApp): Intervention Mapping and User Testing Study.

BACKGROUND: Despite the unequivocal evidence demonstrating the benefits of being physically active, many people do not meet the recommended guidelines of at least 150 minutes of moderate- to vigorous-intensity physical activity per week. This can be changed with the development and implementation of innovative interventions. The use of mobile health (mHealth) technologies has been suggested as a mechanism to offer people innovative health behavior change interventions. OBJECTIVE: This study aims to outline the systematic, theory-driven processes and user testing applied to the development of a smartphone-based physical activity app (SnackApp) to promote participation in a novel physical activity intervention called Snacktivity. The acceptability of the app was explored and reported. METHODS: Intervention mapping involves a 6-step process, the first 4 of which were presented in this study. These steps were used to develop the SnackApp for use within the Snacktivity intervention. The first step involved a needs assessment, which included composing an expert planning group, patient and public involvement group, and gathering the views of the public on Snacktivity and the public perception of the use of wearable technology to support Snacktivity. This first step aimed to determine the overall purpose of the Snacktivity intervention. Steps 2 to 4 involved determining the intervention objectives, the behavior change theory and techniques on which the intervention is based, and the development of the intervention resources (ie, SnackApp). After the completion of steps 1 to 3 of the intervention mapping process, the SnackApp was developed and linked to a commercial physical activity tracker (Fitbit Versa Lite) for the automated capture of physical activity. SnackApp includes provisions for goal setting, activity planning, and social support. Stage 4 involved users (inactive adults, N=15) testing the SnackApp for 28 days. App engagement (mobile app use analytics) was analyzed to determine app use and to inform the further development of SnackApp. RESULTS: Over the study period (step 4), participants engaged with SnackApp an average of 77 (SD 80) times. On average, participants used the SnackApp for 12.6 (SD 47) minutes per week, with most of the time spent on the SnackApp dashboard and engaging, on average, 14 (SD 12.1) times, lasting 7 to 8 minutes per week. Overall, male participants used the SnackApp more than female participants did. The app rating score was 3.5 (SD 0.6) out of 5, suggesting that SnackApp was rated as fair to good. CONCLUSIONS: This study outlines and reports data regarding the development of an innovative mHealth app using a systematic, theory-driven framework. This approach can guide the development of future mHealth programs. User testing of the SnackApp suggested that physically inactive adults will engage with the SnackApp, indicating its applicability of use in the Snacktivity physical activity intervention.

A qualitative longitudinal study of motivation in the REtirement in ACTion (REACT) physical activity intervention for older adults with mobility limitations.

BACKGROUND: Physical activity (PA) is beneficial for older adults' health, however they remain the least active age group in the UK. This qualitative longitudinal study aims to understand motivations in older adults receiving the REACT physical activity intervention, through the lens of self-determination theory. METHODS: Participants were older adults randomised to the intervention arm of the Retirement in ACTion (REACT) Study, a group-based physical activity and behaviour maintenance intervention to prevent decline of physical functioning in older adults (≥ 65 years). Stratified purposive sampling by physical functioning (Short Physical Performance Battery scores) and 3-month attendance was employed. Fifty-one semi-structured interviews were conducted at 6, 12 and 24-months with twenty-nine older adults (Mean age (baseline) = 77.9 years, SD 6.86, 69% female) and at 24-months with twelve session leaders and two service managers. Interviews were audio recorded, transcribed verbatim and analysed using Framework Analysis. RESULTS: Perceptions of autonomy, competence and relatedness were associated with adherence to the REACT programme and maintenance of an active lifestyle. Motivational processes and participants' support needs, changed during the 12-month REACT intervention and across the 12-months post-intervention. Group interactions were an important source of motivation during the first six months but increased competence and mobility drove motivation at the later stages (12 months) and post-intervention (24 months). CONCLUSIONS: Motivational support needs vary in different stages of a 12-month group-based programme (adoption and adherence) and post-intervention (long-term maintenance). Strategies to accommodate those needs include, (a) making exercise social and enjoyable, (b) understanding participants' capabilities and tailoring the programme accordingly, (c) capitalising on group support to motivate participants to try other activities and prepare sustainable active living plans. TRIAL REGISTRATION: The REACT study was a pragmatic multi-centre, two-arm, single-blind, parallel-group, RCT (ISRCTN registration number 45627165).

Motivational support intervention to reduce smoking and increase physical activity in smokers not ready to quit: the TARS RCT.

Background: Physical activity can support smoking cessation for smokers wanting to quit, but there have been no studies on supporting smokers wanting only to reduce. More broadly, the effect of motivational support for such smokers is unclear. Objectives: The objectives were to determine if motivational support to increase physical activity and reduce smoking for smokers not wanting to immediately quit helps reduce smoking and increase abstinence and physical activity, and to determine if this intervention is cost-effective. Design: This was a multicentred, two-arm, parallel-group, randomised (1 : 1) controlled superiority trial with accompanying trial-based and model-based economic evaluations, and a process evaluation. Setting and participants: Participants from health and other community settings in four English cities received either the intervention (n = 457) or usual support (n = 458). Intervention: The intervention consisted of up to eight face-to-face or telephone behavioural support sessions to reduce smoking and increase physical activity. Main outcome measures: The main outcome measures were carbon monoxide-verified 6- and 12-month floating prolonged abstinence (primary outcome), self-reported number of cigarettes smoked per day, number of quit attempts and carbon monoxide-verified abstinence at 3 and 9 months. Furthermore, self-reported (3 and 9 months) and accelerometer-recorded (3 months) physical activity data were gathered. Process items, intervention costs and cost-effectiveness were also assessed. Results: The average age of the sample was 49.8 years, and participants were predominantly from areas with socioeconomic deprivation and were moderately heavy smokers. The intervention was delivered with good fidelity. Few participants achieved carbon monoxide-verified 6-month prolonged abstinence [nine (2.0%) in the intervention group and four (0.9%) in the control group; adjusted odds ratio 2.30 (95% confidence interval 0.70 to 7.56)] or 12-month prolonged abstinence [six (1.3%) in the intervention group and one (0.2%) in the control group; adjusted odds ratio 6.33 (95% confidence interval 0.76 to 53.10)]. At 3 months, the intervention participants smoked fewer cigarettes than the control participants (21.1 vs. 26.8 per day). Intervention participants were more likely to reduce cigarettes by ≥ 50% by 3 months [18.9% vs. 10.5%; adjusted odds ratio 1.98 (95% confidence interval 1.35 to 2.90] and 9 months [14.4% vs. 10.0%; adjusted odds ratio 1.52 (95% confidence interval 1.01 to 2.29)], and reported more moderate-to-vigorous physical activity at 3 months [adjusted weekly mean difference of 81.61 minutes (95% confidence interval 28.75 to 134.47 minutes)], but not at 9 months. Increased physical activity did not mediate intervention effects on smoking. The intervention positively influenced most smoking and physical activity beliefs, with some intervention effects mediating changes in smoking and physical activity outcomes. The average intervention cost was estimated to be £239.18 per person, with an overall additional cost of £173.50 (95% confidence interval -£353.82 to £513.77) when considering intervention and health-care costs. The 1.1% absolute between-group difference in carbon monoxide-verified 6-month prolonged abstinence provided a small gain in lifetime quality-adjusted life-years (0.006), and a minimal saving in lifetime health-care costs (net saving £236). Conclusions: There was no evidence that behavioural support for smoking reduction and increased physical activity led to meaningful increases in prolonged abstinence among smokers with no immediate plans to quit smoking. The intervention is not cost-effective. Limitations: Prolonged abstinence rates were much lower than expected, meaning that the trial was underpowered to provide confidence that the intervention doubled prolonged abstinence. Future work: Further research should explore the effects of the present intervention to support smokers who want to reduce prior to quitting, and/or extend the support available for prolonged reduction and abstinence. Trial registration: This trial is registered as ISRCTN47776579. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 4. See the NIHR Journals Library website for further project information.

NHS pharmacological and behavioural support helps smokers wanting to quit, and physical activity may also help. It is unclear if behavioural support for those not ready to quit may lead to more quit attempts and abstinence from smoking. A total of 915 smokers who wanted to reduce their smoking, but who had not yet quit, were recruited and randomised to receive an intervention or brief support as usual (brief advice to quit), in Plymouth, London, Oxford and Nottingham. The intervention involved up to eight sessions (by telephone or in person) of motivational support to reduce smoking and increase physical activity (and more sessions to support a quit attempt). Participants self-reported smoking and physical activity information at the start of the trial and after 3 and 9 months. Self-reported quitters confirmed their abstinence with a biochemical test of expired air or saliva. Our main interest was in whether or not the groups differed in the proportion who remained abstinent for at least 6 months. Overall, only 1­2% remained abstinent for 6 months. Although it appeared that a greater proportion did so after receiving the intervention, because few participants were abstinent, the results are not conclusive. However, the intervention had beneficial effects on less rigorous outcomes, including a reduction in the self-reported number of cigarettes smoked, and a greater proportion of intervention than control participants with self-reported and biochemically verified abstinence at 3 months. The intervention also helped participants to reduce, by at least half, the number of cigarettes they smoked at 3 and 9 months, and to report more physical activity, but only at 3 months. Despite reasonable intervention engagement and some short-term changes in smoking and physical activity, the trial does not provide evidence that this intervention would help smokers to quit for at least 6 months nor would it be cost-effective, with an average cost of £239 per smoker.

Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking (TARS).

AIMS: For smokers unmotivated to quit, we assessed the effectiveness and cost-effectiveness of behavioural support to reduce smoking and increase physical activity on prolonged abstinence and related outcomes. DESIGN: A multi-centred pragmatic two-arm parallel randomised controlled trial. SETTING: Primary care and the community across four United Kingdom sites. PARTICIPANTS: Nine hundred and fifteen adult smokers (55% female, 85% White), recruited via primary and secondary care and the community, who wished to reduce their smoking but not quit. INTERVENTIONS: Participants were randomised to support as usual (SAU) (n = 458) versus multi-component community-based behavioural support (n = 457), involving up to eight weekly person-centred face-to-face or phone sessions with additional 6-week support for those wishing to quit. MEASUREMENTS: Ideally, cessation follows smoking reduction so the primary pre-defined outcome was biochemically verified 6-month prolonged abstinence (from 3-9 months, with a secondary endpoint also considering abstinence between 9 and 15 months). Secondary outcomes included biochemically verified 12-month prolonged abstinence and point prevalent biochemically verified and self-reported abstinence, quit attempts, number of cigarettes smoked, pharmacological aids used, SF12, EQ-5D and moderate-to-vigorous physical activity (MVPA) at 3 and 9 months. Intervention costs were assessed for a cost-effectiveness analysis. FINDINGS: Assuming missing data at follow-up implied continued smoking, nine (2.0%) intervention participants and four (0.9%) SAU participants achieved the primary outcome (adjusted odds ratio, 2.30; 95% confidence interval [CI] = 0.70-7.56, P = 0.169). At 3 and 9 months, the proportions self-reporting reducing cigarettes smoked from baseline by ≥50%, for intervention versus SAU, were 18.9% versus 10.5% (P = 0.009) and 14.4% versus 10% (P = 0.044), respectively. Mean difference in weekly MVPA at 3 months was 81.6 minutes in favour of the intervention group (95% CI = 28.75, 134.47: P = 0.003), but there was no significant difference at 9 months (23.70, 95% CI = -33.07, 80.47: P = 0.143). Changes in MVPA did not mediate changes in smoking outcomes. The intervention cost was £239.18 per person, with no evidence of cost-effectiveness. CONCLUSIONS: For United Kingdom smokers wanting to reduce but not quit smoking, behavioural support to reduce smoking and increase physical activity improved some short-term smoking cessation and reduction outcomes and moderate-to-vigorous physical activity, but had no long-term effects on smoking cessation or physical activity.

Snacktivity™ to promote physical activity and reduce future risk of disease in the population: protocol for a feasibility randomised controlled trial and nested qualitative study.

BACKGROUND: Many people do not regularly participate in physical activity, which may negatively impact their health. Current physical activity guidelines are focused on promoting weekly accumulation of at least 150 min of moderate to vigorous intensity physical activity (MVPA). Whilst revised guidance now recognises the importance of making small changes to physical activity behaviour, guidance still focuses on adults needing to achieve at least 150 min of MVPA per week. An alternative 'whole day' approach that could motivate the public to be more physically active, is a concept called Snacktivity™. Instead of focusing on achieving 150 min per week of physical activity, for example 30 min of MVPA over 5 days, Snacktivity™ encourages the public to achieve this through small, but frequent, 2-5 min 'snacks' of MVPA throughout the whole day. METHODS: The primary aim is to undertake a feasibility trial with nested qualitative interviews to assess the feasibility and acceptability of the Snacktivity™ intervention to inform the design of a subsequent phase III randomised trial. A two-arm randomised controlled feasibility trial aiming to recruit 80 inactive adults will be conducted. Recruitment will be from health and community settings and social media. Participants will be individually randomised (1:1 ratio) to receive either the Snacktivity™ intervention or usual care. The intervention will last 12 weeks with assessment of outcomes completed before and after the intervention in all participants. We are interested in whether the Snacktivity™ trial is appealing to participants (assessed by the recruitment rate) and if the Snacktivity™ intervention and trial methods are acceptable to participants (assessed by Snacktivity™/physical activity adherence and retention rates). The intervention will be delivered by health care providers within health care consultations or by researchers. Participants' experiences of the trial and intervention, and health care providers' views of delivering the intervention within health consultations will be explored. DISCUSSION: The development of physical activity interventions that can be delivered at scale are needed. The findings from this study will inform the viability and design of a phase III trial to assess the effectiveness and cost-effectiveness of Snacktivity™ to increase physical activity. TRIAL REGISTRATION: ISRCTN: 64851242.

Intervention fidelity assessment: A sub-study of the Norfolk Diabetes Prevention Study (NDPS).

BACKGROUND: Previous research has shown that lifestyle modification can delay or prevent the onset of type 2 diabetes in high-risk individuals. The Norfolk Diabetes Prevention Study (NDPS) was a parallel, three-arm, randomized controlled trial with up to 46 months follow-up that tested a group-delivered, theory-based lifestyle intervention to reduce the incidence of type 2 diabetes in high-risk groups. The current study aimed to evaluate if the NDPS intervention was delivered to an acceptable standard and if any part(s) of the delivery required improvement. METHODS: A sub-sample of 30, 25 for inter-rater reliability and audio-recordings of the NDPS intervention education sessions were assessed independently by two reviewers (CT, TW) using a 12-item checklist. Each item was scored on a 0-5 scale, with a score of 3 being defined as 'adequate delivery'. Inter-rater reliability was assessed. Analysis of covariance (ANCOVA) was used to assess changes in intervention fidelity as the facilitators gained experience. RESULTS: Inter-rater agreement was acceptable (86%). A mean score of 3.47 (SD = .38) was achieved across all items of the fidelity checklist and across all intervention facilitators (n = 6). There was an apparent trend for intervention fidelity scores to decrease with experience; however, this trend was non-significant (p > .05) across all domains in this small sample. CONCLUSION: The NDPS was delivered to an acceptable standard by all Diabetes Prevention Facilitators. Further research is needed to better understand how the intervention's delivery characteristics can be optimized and how they might vary over time.

A process evaluation, with mediation analysis, of a web-based intervention to augment primary care exercise referral schemes: the e-coachER randomised controlled trial.

BACKGROUND: The e-coachER trial aimed to determine whether adding web-based behavioural support to exercise referral schemes (ERS) increased long-term device-measured physical activity (PA) for patients with chronic conditions, compared to ERS alone, within a randomised controlled trial. This study explores the mechanisms of action of the e-coachER intervention using measures of the behaviour change processes integral to the intervention's logic model. METHODS: Four hundred fifty adults with obesity, diabetes, hypertension, osteoarthritis or history of depression referred to an ERS were recruited in Plymouth, Birmingham and Glasgow. The e-coachER intervention comprising 7-Steps to Health was aligned with Self-Determination Theory and mapped against evidence-based behaviour change techniques (BCTs). Participants completed questionnaires at 0, 4, and 12 months to assess PA and self-reported offline engagement with core BCTs in day-to-day life (including action planning and self-monitoring) and beliefs relating to PA (including perceived importance, confidence, competence, autonomy and support). We compared groups at 4 and 12 months, controlling for baseline measures and other covariates. Mediation analysis using the product of coefficients method was used to determine if changes in process variables mediated intervention effects on moderate to vigorous physical activity (MVPA) recorded by accelerometer and self-report at 4- and 12-months. RESULTS: The internal reliability (Cronbach's alpha) for all multi-item scales was > 0.77. At 4-months, those randomised to e-coachER reported higher levels of PA beliefs relating to importance (1.01, 95% confidence interval (CI): 0.42 to 1.61, p = 0.001), confidence (1.28, 95% CI: 0.57 to 1.98, p < 0.001), competence (1.61, 95% CI: .68 to 2.54, p = 0.001), availability of support (0.77, 95% CI: 0.07 to 1.48, p = 0.031), use of action planning (1.54, 95% CI: 0.23 to 2.85, p = 0.021) and use of self-monitoring (0.76, 95% CI: 0.19 to 1.32, p = 0.009) compared to ERS alone. There were no intervention effects on autonomous beliefs or perceived frequency of support, compared to ERS alone. At the 12-month follow-up, participants belief in the importance of PA was the only process measure to remain significantly higher in the e-coachER group when compared to ERS alone (0.75, 95% CI: 0.05 to 1.45). Intervention effects on perceived importance (2.52, 95% CI: 0.45 to 5.39), action planning (1.56, 95% CI: 0.10 to 3.54) and self-monitoring (1.92, 95% CI: 0.21 to 4.33) at 4-months significantly mediated change in accelerometer measured MVPA at 12-months (recorded in ≥ 10-min bouts). CONCLUSIONS: e-coachER led to some short-term changes in most process outcomes. Some of these processes also appeared to mediate e-coachER effects on changes in accelerometer measured MVPA. Further work should be carried out to understand how best to design and implement theoretically underpinned web-based physical activity promotion interventions within ERS. TRIAL REGISTRATION: ISRCTN, ISRCTN15644451 . Registered 12 February 2015.

Barriers and facilitators to implementation of a home-based cardiac rehabilitation programme for patients with heart failure in the NHS: a mixed-methods study.

OBJECTIVES: This study aimed to identify barriers to, and facilitators of, implementation of the Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme within existing cardiac rehabilitation services, and develop and refine the REACH-HF Service Delivery Guide (an implementation guide cocreated with healthcare professionals). REACH-HF is an effective and cost-effective 12-week home-based cardiac rehabilitation programme for patients with heart failure. SETTING/PARTICIPANTS: In 2019, four early adopter 'Beacon Sites' were set up to deliver REACH-HF to 200 patients. In 2020, 5 online REACH-HF training events were attended by 85 healthcare professionals from 45 National Health Service (NHS) teams across the UK and Ireland. DESIGN: Our mixed-methods study used in-depth semi-structured interviews and an online survey. Interviews were conducted with staff trained specifically for the Beacon Site project, identified by opportunity and snowball sampling. The online survey was later offered to subsequent NHS staff who took part in the online REACH-HF training. Normalisation Process Theory was used as a theoretical framework to guide data collection/analysis. RESULTS: Seventeen healthcare professionals working at the Beacon Sites were interviewed and 17 survey responses were received (20% response rate). The identified barriers and enablers included, among many, a lack of resources/commissioning, having interest in heart failure and working closely with the clinical heart failure team. Different implementation contexts (urban/rural), timing (during the COVID-19 pandemic) and factors outside the healthcare team/system (quality of the REACH-HF training) were observed to negatively or positively impact the implementation process. CONCLUSIONS: The findings are highly relevant to healthcare professionals involved in planning, delivering and commissioning of cardiac rehabilitation for patients with heart failure. The study's main output, a refined version of the REACH-HF Service Delivery Guide, can guide the implementation process (eg, designing new care pathways) and provide practical solutions to overcoming common implementation barriers (eg, through early identification of implementation champions).

Exploring the views of patients' and their family about patient-initiated follow-up in head and neck cancer: A mixed methods study.

OBJECTIVE: The objective of this work was to explore head and neck cancer (HNC) patients' and their family members' views on acceptability and feasibility of patient-initiated follow-up (PIFU), including concerns and anticipated benefits. METHODS: Patients were recruited from UK HNC clinics, support groups and advocacy groups. They completed a survey (n = 144) and/or qualitative interview (n = 30), three with a family member. Qualitative data were analysed thematically, quantitative data using descriptive statistics. RESULTS: Preference for follow-up care in HNC was complex and individual. Many patients thought PIFU could beneficially reallocate health care resources and encourage self-management. Patients' main concerns with PIFU were losing the reassurance of regular clinic appointments and addressing mental well-being needs within PIFU, possibly using peer support. Patients were concerned about their ability to detect recurrence due to lack of expertise and information. They emphasised the importance of a reliable, direct and easy urgent appointment service and of feeling supported and heard by clinicians. Patients believed family and friends need support. CONCLUSION: PIFU may be feasible and acceptable for certain HNC patients, providing it addresses support for mental well-being, provides quick, reliable and direct clinician access and information on "red flag" symptoms, and ensures patients and their caregivers feel supported.